Evaluation of the Safety and Effectiveness of BELKYRA® Inj. for the Treatment of Patients With Submental Fullness Due to Submental Fat: A Postmarketing Surveillance Study in Korea

Allergan

Status: Terminated

Conditions: Submental Fullness

Treatments: Drug: BELKYRA Inj.

Study type: Observational

Funder types: Industry

Identifiers

NCT03691415

CMO-EPI-FAS-0537

EUPAS23762 (Other Identifier)

Details and patient eligibility

About

The purpose of this PMS study is to evaluate the safety and effectiveness of BELKYRA Inj. used according to the dose specified in the instructions for use, for the treatment of patients with SM fullness due to SMF, through active investigation under routine clinical practice

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible and consenting Korean patients
• Patients who have consented to the study and who have signed the private information protection act form or ICF

Exclusion criteria

• Patients having infection at the infection sites
• Patients presenting evidence of causes of enlarged submental area other than localized submental fat (E.g.: thyroid enlargement, enlarged submental salivary glands, cervical lymphadenopathy, etc.)
• Patients participating in an interventional clinical study, currently or within 30 days before enrollment, will not be eligible for inclusion in the study
• Pregnant women
• Renal impairment patients
• Hepatic impairment patients
• Patients with severe laxity

Trial design

71 participants in 1 patient group

BELKYRA Inj.

Description:

Each patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart and follow-up within 3 months of the last treatment session.

Treatment:

Drug: BELKYRA Inj.